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Updated: Jul 10, 2026

A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
Published on: February 11, 2019
[Clinical assessment of drug safety]
1Centre régional de pharmacovigilance d'Alsace, Hôpital civil, 1, place de l'Hôpital, F 67000 Strasbourg. jean-louis.imbs@pharmaco-ulp.u-strasbg.fr
Abstract:
The environment of drug safety is changing. In addition to the current system of pharmacovigilance based on spontaneous report of adverse events, clinical data observed in a given patient with a given symptom is taken into consideration and compared with information coming from pharmacovigilance data bases, which is then analyzed for causality by the experts of both the promotor and the public network. Such information is integrated into a risk management strategy, defined together by the French drug agency (Afssaps) and the marketing authorization holder. This strategy includes a pharmacovigilance plan and, if possible, a risk minimisation plan.
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